Transcription of REGULATORY REQUIREMENTS FOR …
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CHAPTER 1 REGULATORY REQUIREMENTS FOR pharmaceutical plants Introduction When we design a pharmaceutical plant we need to understand and follow the basic REGULATORY REQUIREMENTS for the construction of a pharmaceutical plant. These REQUIREMENTS are mainly divided into two categories namely - REQUIREMENTS related to good manufacturing practices currently followed in pharmaceutical industry. These are elaborately describe in the various international cGMP guidelines. REQUIREMENTS related to Factories Acts and Rules, which is a Central Act and the rules described separately by each state in India, for this work we have referred the rules specified by the state of Maharashtra.
Regulatory Requirements for Pharmaceutical Plants | 3 and men, Availability of trained or skilled man power, Labour and industrial legislations, cost of living, etc.
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